Five long years after the publication of the now-notorious Katsanos paper, the U.S. FDA has issued a final determination about whether devices indicated for treatment of peripheral artery disease carry the threat of excess mortality when using paclitaxel as an antiproliferative.
Boston Scientific Corp. said that three-year primary patency and the four-year freedom from target lesion revascularization (TLR) rate for patients treated with the Ranger drug-coated balloon (DCB), in the Ranger II superficial femoral artery (SFA) study, are the best ever reported data for randomized trials using DCBs.
Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national regulatory authorities as a factor in scotching the proposed acquisition, the second time in recent weeks that government agencies have grounded mergers and acquisitions in the med-tech space.
Pulsed field ablation (PFA) seems to have seized the moment in the field of cardiac electrophysiology, given its seemingly superior performance over other ablation modalities as a treatment for atrial fibrillation (AF). New data from three studies were presented at this year’s annual meeting of the Heart Rhythm Society that further confirm the value of PFA as a treatment for both persistent and paroxysmal AF with data sets that seem to confirm that PFA is poised to sweep aside the current standards for ablation, potentially overturning a treatment paradigm that took decades to establish.
Recent developments may seem to have rendered artificial intelligence (AI) little more than the latest internet sensation, but a presentation at this year’s annual meeting of the Heart Rhythm Society confirms yet again that AI is much more than just a trend. A new AI algorithm paired with a single-lead electrocardiogram accurately predicted the onset of ventricular tachycardia in 88% of patients in an outcome that could enable cardiologists to thwart thousands of sudden cardiac death (SCD) events each year, potentially ushering in a new age of cardiac care across the globe.
The FDA gave the greenlight to Route 92 Medical Inc. for its Freeclimb 70 reperfusion system in the treatment of ischemic stroke. The 510(k) clearance includes a Freeclimb 70 aspiration catheter, as well as a Tenzing 7 delivery catheter.
Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat patients with iliac arterial occlusive disease, a type of peripheral arterial disease where atherosclerosis narrows and blocks peripheral arteries.
